Immunoassays have been used in recent years to detect the presence of infectious diseases. In order for the assay to be useful, it must detect a particular organism with a high degree of reliability. In most cases, this requires the isolation and reaction of antigens peculiar to the organism with corresponding antibodies. For the test to be commercially successful, it also needs to be relatively inexpensive, simple to use and rapid.
One such organism which can be detected by immunoassay is herpes simplex virus. Despite the increasing control of various viruses by vaccination or treatment with various anti-viral agents, infection by herpes simplex virus (identified herein as HSV) remains a serious problem. There are two types of HSV: type 1 which occurs mainly around the mouth, and type 2 which occurs primarily around the genital area of the human body. Skin infections and viral encephalitis are but two of the serious results from HSV infection.
Because of the widespread nature of herpes simplex viral infection, there is considerable interest in having a rapid, simple and reliable test for detection of the causative virus. However, there are several similar viruses which often are indistinguishable from HSV using known diagnostic procedures. Thus, a useful diagnostic test for HSV-1 or HSV-2 must be specific for these viruses only and must not be sensitive to viruses such as Epstein-Barr virus, cytomegalovirus, varicella zoster virus or any other flora.
Various methods have been developed to determine viruses including culture techniques, immunoelectrophoresis, enzyme linked immunosorbent assays (ELISA) and agglutination assays (see for example, U.S. Pat. Nos. 4,430,437 issued Feb. 7, 1984 to Hampar et al and 4,695,537 issued Sep. 22, 1987 to Dorsett).
There is a need in the art for an assay for directly detecting herpes simplex viral antigen on a solid support with the advantages of known methods, but with improved sensitivity and accuracy.